Comparison · NCT03382600-sae
Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) vs Pembrolizumab + Cisplatin +TS-1 (Cohort 2): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) vs Pembrolizumab + Cisplatin +TS-1 (Cohort 2): serious adverse events. Trial comparisons, record NCT03382600-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03382600-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.5 | 0.371 | 0.629 | wilson | |
| Risk in group 2 | 0.478 | 0.341 | 0.619 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0217 | -0.169 | 0.21 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.699 | 1.56 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.497 | 2.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) than on Pembrolizumab + Cisplatin +TS-1 (Cohort 2) | 46 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pembrolizumab + Oxaliplatin +TS-1 (Cohort 1) | Participants received pembrolizumab 200 mg Q3W plus oxaliplatin 130 mg/m\^2 Q3W by IV infusion plus TS-1 BID by continuous oral administration for 14 days, followed by a recovery period of 7 days. Study treatment started on Day 1 of each 3-week course, and continued for up to \~3 years. | 27 | 54 | EG000 |
| Group 2 | Pembrolizumab + Cisplatin +TS-1 (Cohort 2) | Participants received pembrolizumab 200 mg Q3W plus cisplatin 60 mg/m\^2 Q3W by IV infusion plus TS-1 BID by continuous oral administration for 14 days, followed by a recovery period of 7 days. Study treatment started on Day 1 of each 3-week course, and continued for up to \~3 years. | 22 | 46 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to ~36 months
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as First Line Chemotherapy in Gastric Cancer (MK-3475-659/KEYNOTE-659)
- NCT number
- NCT03382600
- Phases
- PHASE2
- Conditions
- Gastric Cancer
- Interventions
- Pembrolizumab, Oxaliplatin, TS-1, Cisplatin
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-12-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03382600?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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